This excerpt taken from the ELN 6-K filed Apr 11, 2005.
(A) Revenue from Retained Products
Total revenue from retained products increased to $301.1 million in 2004 from $271.9 million in 2003, an increase of 11%. The increase primarily reflected the growth in prescriptions and demand for Maxipime and Azactam, growth in contract manufacturing and royalties and initial sales of Tysabri. The basic patent on Maxipime expires in March 2007 and the patent on Azactam expires in October 2005. Two U.S. patents covering Maxipime formulations may provide patent protection until 2008. The expiration of these patents is expected to result in generic competition for these products, which could adversely impact future revenues.
As reported by IMS Health National Sales Perspectives, Maxipime prescription demand for 2004 increased by 14% over 2003, while revenues increased from $109.1 million to $117.5 million, or 8%. Azactam prescription demand for 2004 increased by 12% over the same period in 2003, corresponding to increased revenues from $45.1 million to $50.6 million, or 12%. The difference between prescription and revenue growth rates is due to changing wholesaler inventory levels.
The FDA granted accelerated approval of Tysabri in late November 2004 for the treatment of patients in the U.S. with all forms of relapsing remitting MS. Revenue from Tysabri amounted to $6.4 million in 2004. The marketing and clinical dosing of Tysabri was voluntarily suspended in February 2005.
Contract manufacturing and royalty revenues are as follows:
Contract manufacturing and royalty revenue comprises revenue earned from products we manufacture for third parties, and royalties we earn on sales by third parties of products that incorporate our technologies. Contract manufacturing and royalty revenues increased 8% from $117.7 million in 2003 to $126.6 million in 2004. The increase was primarily related to additional manufacturing activities. Aside from Verelan, Diltiazem and Skelaxin, no other single product accounted for more than 10% of our contract manufacturing and royalty revenues in either 2004 or 2003.